Zilver® PTX™ Global Registry

Cook Group

Status: Completed

Conditions: Peripheral Vascular Disease; Peripheral Arterial Disease

Treatments: Device: Zilver® PTX™ Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01094678

05-518

100010 (Other Identifier)

Details and patient eligibility

About

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

Enrollment: 788 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stenosis of the above-the-knee femoropopliteal artery
• appropriate size and location of the lesion

Exclusion criteria

• pregnant or breast feeding
• failure or inability to give informed consent
• simultaneously participating in another drug or device study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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788 participants in 1 patient group

Stent

Experimental group

Treatment:

Device: Zilver® PTX™ Stent